Gluten Technology and Education for Celiac Health

Description

The investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. If successful, the proposed intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.

Conditions

Celiac Disease

Study Overview

Study Details

Study overview

The investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. If successful, the proposed intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.

Gluten Technology and Education for Celiac Health

Gluten Technology and Education for Celiac Health

Condition
Celiac Disease
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Chicago Medical Center, Chicago, Illinois, United States, 60637

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Any gender; Age 18-75 years
  • * Celiac disease diagnosis by serology and duodenal biopsy (corresponding to •Marsh 3 histology), adequate sampling and interpretable villus height to crypt depth ratio upon review by our study pathologist
  • * Diagnosed with celiac disease within 4 months of initial study screening
  • * Willingness to use gluten-detection technology
  • * Not currently using a gluten detection technology that tests for gluten in urine or stool
  • * Seeing a clinician at one of the four recruitment sites
  • * Having already had an initial dietitian visit at one of the participating celiac disease centers
  • * Currently pregnant or planning to become pregnant during the study
  • * Not planning to follow a gluten-free diet
  • * Concurrent participation in a clinical trial of an experimental pharmacologic agent (for any condition).

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Benjamin Lebwohl, MD, MS, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2028-08-31